ISRCTN78768405
Completed
Not Applicable
Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)
ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)0 sites246 target enrollmentJune 7, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
- Enrollment
- 246
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 3 to 24 months
- •2\. Suspected malaria with no other obvious cause of illness
- •3\. P. falciparum asexual parasitaemia greater than \+\+ (5 \- 10 parasites/High Power Field \[HPF])
- •4\. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so)
- •5\. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five)
- •6\. Parent/guardian informed consent
Exclusion Criteria
- •1\. Ability to tolerate oral intake
- •2\. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours
- •3\. History of allergy to artemisinin compounds and/or quinine
Outcomes
Primary Outcomes
Not specified
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